国产与进口替莫唑胺胶囊在Beagle犬体内的生物等效性研究

发布时间：2018-05-12 00:41

  本文选题：替莫唑胺 + 生物等效性　； 参考：《中国新药杂志》2015年04期

【摘要】：目的:研究国产与进口替莫唑胺胶囊在Beagle犬体内的药动学及生物等效性。方法:6只Beagle犬随机交叉单剂量口服进口替莫唑胺胶囊(参比制剂)和国产替莫唑胺胶囊(受试制剂),采用HPLC法测定犬血浆中替莫唑胺的浓度,Bapp 3.0软件计算其主要药动学数据,并进行两种制剂的等效性评价。结果:参比制剂与受试制剂的Cmax分别为(11.35±1.35)和(11.70±2.77)μg·m L-1;Tmax分别为(0.97±0.56)和(1.08±0.49)h;t1/2β分别为(1.44±0.37)和(1.43±0.24)h;AUC0~t分别为(27.34±2.30)和(28.34±7.47)μg·h·m L-1,AUC0~∞分别为(29.85±4.49)和(30.85±8.46)μg·h·m L-1。受试制剂对参比制剂的相对生物利用度为(106.1±36.1)%。结论:本实验结果表明,两种替莫唑胺胶囊在Beagle犬体内具有生物等效性。
[Abstract]:Aim: to study the pharmacokinetics and bioequivalence of domestic and imported temozolidomide capsules in Beagle dogs. Methods six Beagle dogs were randomly cross-administered with imported temozolidomide capsule (reference preparation) and domestic temozolidomide capsule (test preparation). The main pharmacokinetic data of temozolidomide in dog plasma were determined by HPLC method and the software Bapp 3.0 was used to calculate the main pharmacokinetic data. The equivalence of the two preparations was evaluated. Results: the Cmax of reference preparation and test preparation were 11.35 卤1.35) and 11.70 卤2.77 渭 g ml 路L ~ (-1) T _ (max), respectively (0.97 卤0.56) and 1.08 卤0.49 h ~ (-1 / 2) 尾 were 1.44 卤0.37) and 1.43 卤0.24 h AUC _ (0T) were 27.34 卤2.30) and 28.34 卤7.47 渭 g h m L ~ 鈭，

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